Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK093AB | OT / LL |
administration of an extra dose of Hib vaccine on a patient, with no reported adverse event; Initial information received on 17-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administration an extra dose of HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel) for Immunisation. On 15-Jul-2025, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK093AB, expiry date 30-Sep-2025; strength not reported) via intramuscular route in the left thigh for Immunization and extra dose was administered with no reported adverse event (extra dose administered) (latency same day). Reportedly, ACTHIB and Pentacel were administered on the same day. She wanted to know any safety information in relation to this incident Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pentacel